Enrolled women will undergo a bilateral 2-view DE-CEDM examination after administration of an iodinated contrast agent. Separate readers on-site will evaluate DE-CEDM+MX (standard mammography) and CE-BMRI+MX to determine the extent of disease. An integrated reading of both sets of images will be performed either by one or the two readers. DE-CEDM will not be used to change the diagnosis. Lesions that are confirmed as suspicious by MX, CE-BMRI, or follow-up breast ultrasound (US) will undergo biopsy. Truth about extent of disease will be based on histologic analysis of surgical specimens along with follow-up MX 10-15 months after the study exam. A randomized, blinded image evaluation will be done with 11 to 15 radiologist readers to compare DE-CEDM+MX and CE-BMRI+MX for assessment of disease extent.

DE-CEDM - CE-BMRI Comparison for the identification of women whose clinical management would be changed (defined as: presence of additional foci in the contralateral breast, and/or presence of additional foci at least 2 cm from the primary cancer in the ipsilateral breast, and/or change in size of the primary by at least 2 cm).

Estimated Enrollment:

350

Study Start Date:

April 2010

Estimated Primary Completion Date:

October 2012 (Final data collection date for primary outcome measure)

Intervention Details:

Other: DE-CEDM and CE-BMRI

Comparison between DE-CEDM and CE-BMRI

Eligibility

Ages Eligible for Study:

21 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Woman 21 years of age or older

The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.

Newly diagnosed with Breast Cancer (DCIS or invasive) identified through core biopsy or fine-needle aspiration (FNA) within last 30 days.

Will have or have had a bilateral CE-BMRI performed within 30 days AFTER the new breast cancer diagnosis.

Woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303419